Glass ampules are widely used for containing pharmaceuticals. Glass ampules typically have a cylindrical base, a narrowed-down neck and a tapered tip. Glass ampules are used to hold pharmaceuticals to eliminate contamination of the pharmaceutical by contact with anything but glass. However, to gain access to the pharmaceutical within the ampule, the user needs to break the ampule. This is accomplished by applying a lateral force on the tip which snaps the ampule at the neck, thus severing the tip from the base of the ampule. The health care worker then inserts the tip of a needle of a syringe into the open ampule and withdraws a desired amount of pharmaceutical from the ampule.
One of the obvious problems with this system is that fine glass fragments can be withdrawn into the syringe. One way to prevent this is to use a needle having a filter. After withdrawing the pharmaceutical into the barrel of the syringe, the filter needle is then replaced with a conventional needle and the injection can be given. This, of course, creates an extra step, increases the chance of a needle stick and increases the cost of the injection.
Another problem with ampules is that they are a single-use container. That is, once the ampule is opened it cannot be resealed for later use. To get around this, vials are often used to contain a pharmaceutical. Vials are commonly cylindrical containers having an end covered by a pierceable, self-sealing elastomeric material, generally referred to as a septum. To remove a portion of the contents of a vial, the health care worker typically inverts the vial so that the septum faces down, inserts a sterile needle cannula of a syringe through the septum, injects some air into the vial to create a positive pressure in the vial and then withdraws the desired amount of liquid pharmaceutical from the vial into the syringe. The needle is then removed from the septum which automatically reseals itself to keep the contents free from contamination for later use.
Certain pharmaceuticals are stored as two separate components for maximum efficacy and shelf life. One such pharmaceutical is human growth hormone, often referred to as hGH. hGH is generally distributed in a lyophilized form. The lyophilized hGH is then mixed with a diluent prior to use. This is commonly accomplished in the following manner. The ampule is broken open and the tip is discarded. The contents of the ampule are drawn into a transfer syringe through a filter needle. The filter needle is replaced with a fresh needle, preferably another filter needle. The septum of the vial containing the lyophilized hGH is pierced with the needle, the contents of the transfer syringe are injected into the vial and then the needle is withdrawn from the vial septum. The contents of the vial are then accessed in a conventional manner using an injection syringe.